FDA-Drug2024-10-23Class II
Duloxetine Delayed-Release Capsules, USP, 20mg, Rx Only, 500-count bottles, Mfr. by: Towa Pharmaceutical Europe, S.L. Distributed by: BPI, NDC 51991-746-05.
Breckenridge Pharmaceutical, Inc
Hazard
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
Sold states
Product was distributed nationwide within the United States
Affected count
7,107 bottles
Manufactured in
15 Massirio Dr Ste 201, Berlin, CT, United States
Products
Duloxetine Delayed-Release Capsules, USP, 20mg, Rx Only, 500-count bottles, Mfr. by: Towa Pharmaceutical Europe, S.L. Distributed by: BPI, NDC 51991-746-05.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0009-2025Don't want to check this manually?
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